Greater Boston
Pharmacovigilance Medical Director Connect with me using: ►►► [email protected] ◄◄◄ *************** Provide technical leadership to a team of global safety physicians for pharmacovigilance of investigational and marketed products. ***************
Led enterprise-wide initiatives to strengthen the quality, consistency, and medical rigor of Individual Case Safety Report (ICSR) review and causality assessment across global pharmacovigilance operations at Takeda, one of the world's top ten pharmaceutical companies by revenue. Support pharmacovigilance for Oncology, Gastroenterology, Neuroscience, Rare Diseases, Plasma-Derived Therapies, and Vaccines. Serve as subject matter expertise for global regulatory inspections.
Applied epidemiological principles to enhance medical review of adverse event cases in support of pharmacovigilance focused on serving people with rare diseases and other highly specialized conditions. Company acquired by Takeda. Contracted with BioPoint.
Played a global role in designing and implementing safety strategies at a product portfolio level and served as a global product safety lead. Provided scientific expertise/recommendations with respect to product level benefit risk to ensure safe use of product of their responsibility. Responsible for ensuring the product matrix organization within Global Drug Safety is functioning as designed and served as a product safety expert in the company matrix team interacting with Clinical Operations, Regulatory Affairs, Medical Affairs, and Quality Assurance. Performed medical review of adverse event cases for assigned products, both from clinical trials and post-marketing, for seriousness, expectedness and causality. Reviewed MedDRA coding of adverse events in Oracle Argus database. Participated in label review and revision. Complied with ICH, EU GVP, FDA regulations pertaining to Global Drug Safety. Assisted with creation of PBRER aggregate reports, signal detection, adverse event surveillance, company core safety information (CCSI), risk management plan, and reference safety information (RSI) for Investigator Brochures. United Therapeutics is a Forbes Global 2000 biotechnology company. Recognized in "Top 10 Corporate Citizens" (Just Capital).
Performed medical review of adverse event cases for assigned products, both from clinical trials and post-marketing, for seriousness, expectedness and causality.
Supported headquarters of federal agencies. Focused on clinical aspects of data review, cleaning, visualization and data trend identification. Collaborated with multidisciplinary researchers on the design, analytics, interpretation, and communication of results of real world evidence (RWE) studies. Promoted novel and innovative analytic techniques for military traumatic brain injury clinical outcome assessments. Drafted federal regulations for publication in Federal Register. Reviewed individual cases for regulatory Board. Conducted medical affairs for biodefense and pandemic influenza preparedness. Launched neuroscience research study by coordinating between Commandant of the Marine Corps, Director of the National Institute of Mental Health, Department of Veterans Affairs (VA), University of California at San Diego and Navy Bureau of Medicine.
GS-15 Medical Officer (Public Health) Promoted health diplomacy during Public Health Emergency of International Concern (PHEIC) under guidance of the U.S. Ambassador to Indonesia. Advised on epidemiology of Influenza A(H5N1), influenza surveillance, outbreak investigation, public health emergency preparedness, pandemic influenza vaccine production, and CDC cooperative agreements.